Surgical hand access apparatus

ABSTRACT

A surgical access apparatus includes a housing member defining a housing axis and a passageway therethrough, a first seal member mounted across the passageway and having at least one expansible segment adapted to facilitate radial movement of the seal passage during manipulation of the object within the first seal member and a second seal member mounted across the passageway distal of the first seal member and being arranged about a second seal axis radially displaced from the first seal axis. The second seal member includes at least one expansible segment dimensioned to facilitate radial movement of the seal passage of the second seal member during manipulation of the object.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application, Ser. No.11/095,340, filed Mar. 31, 2005, now U.S. Pat. No. 7,766,824, “SURGICALHAND ACCESS APPARATUS” issued on Aug. 3, 2010, the entire contents ofwhich are incorporated herein by reference.

BACKGROUND

1. Field of the Disclosure

The present disclosure relates generally to surgical devices forfacilitating sealed access across a body wall and into a body cavityand, more particularly, to a surgical access apparatus adaptable to forma seal about either the surgeon's hand and/or surgical instrumentsduring laparoscopic and endoscopic surgical procedures.

2. Description of the Related Art

Minimally invasive surgical procedures including both endoscopic andlaparoscopic procedures permit surgery to be performed on organs,tissues and vessels far removed from an opening within the tissue.Laparoscopic and endoscopic procedures generally require that anyinstrumentation inserted into the body be sealed, i.e. provisions mustbe made to ensure that gases do not enter or exit the body through theincision as, e.g., in surgical procedures in which the surgical regionis insufflated. These procedures typically employ surgical instrumentswhich are introduced into the body through a cannula. The cannula has aseal assembly associated therewith. The seal assembly provides asubstantially fluid tight seal about the instrument to preserve theintegrity of the established pneumoperitoneum.

Minimally invasive procedures have several advantages over traditionalopen surgery, including less patient trauma, reduced recovery time,reduced potential for infection, etc. However, despite its recentsuccess and overall acceptance as a preferred surgical technique,minimally invasive surgery, such as laparoscopy, has severaldisadvantages. In particular, surgery of this type requires a great dealof surgeon skill in order for the surgeon to manipulate the long narrowendoscopic instruments about a remote site under endoscopicvisualization. In addition, in laparoscopic surgery involving theintestinal tract, it is often preferable to manipulate large sections ofthe intestines to perform the desired procedure. These manipulations arenot practical with current laparoscopic tools and procedures accessingthe abdominal cavity through a trocar or cannula.

To address these concerns, recent efforts have focused on hand-assistedlaparoscopic techniques and procedures. These procedures incorporateboth laparoscopic and conventional surgical methodologies. The handassisted technique is performed in conjunction with a hand access sealwhich is an enlarged device positionable within the incision in, e.g.,the insufflated abdominal cavity. The device includes a seal for forminga seal about the surgeon's arm upon insertion while permitting surgicalmanipulation of the arm within the cavity. However, known hand accessseals are quite cumbersome and incorporate elaborate sealing mechanisms.Moreover, these hand access seals are ill-adapted to accommodate radialmanipulation of the surgeon's arm within the seal.

SUMMARY

Accordingly, the present disclosure relates to a surgical accessapparatus adaptable to permit the sealed insertion of either thesurgeon's hand and/or surgical instruments during laparoscopic andendoscopic surgical procedures. In one preferred embodiment, thesurgical access apparatus includes an access member having a passagewaytherethrough and first and second seal members mounted across thepassageway. The first seal member includes an inner seal portion and anouter seal portion. The inner seal portion has an aperture forsubstantial sealed reception of an object inserted therein and isarranged about a first seal axis. The outer seal portion includes atleast one expansible rib dimensioned to facilitate movement of theaperture to a displaced position radially displaced from the first sealaxis upon insertion of the object therethrough. The second seal memberalso has an inner portion defining an aperture for substantial sealedreception of the object and is arranged about a second seal axisradially displaced from the first seal axis. Preferably, the aperturesof the first and second seal members are in non-overlapping relation andform a substantial seal within the passageway of the access member inthe absence of the object inserted within the aperture of the firstmember. The first seal member is adapted to move to the displacedposition upon insertion of the object therethrough whereby the aperturesof the first seal member and the second seal member overlap. The outerseal portion of the first seal member may include a plurality ofexpansible ribs. The expansible ribs may be arranged along respectivelines of intersection with the first seal axis of the first seal member.

In another preferred embodiment, the surgical access apparatus includesan access member having a passageway therethrough and a seal membermounted across the passageway. The seal member includes an inner sealportion and an outer seal portion. The inner seal portion has anaperture for substantial sealed reception of an object inserted thereinand is arranged about a seal axis. The outer seal portion includes atleast one expansible rib dimensioned to facilitate movement of theaperture to a displaced position radially displaced from the seal axisupon insertion of the object therethrough. The at least one expansiblerib is generally arranged along a line of intersection with the sealaxis of the seal member. The access member may further include a secondseal member mounted adjacent the first seal member. The second sealmember has an inner portion defining an aperture for substantial sealedreception of the object and is arranged about a second seal axisradially displaced from the first-mentioned seal axis. The first sealmember is preferably adapted to move to the displaced position uponinsertion of the object therethrough whereby the apertures of the firstseal member and the second seal member overlap.

In another preferred embodiment, the surgical hand access apparatusincludes a liner base adapted for insertion through an opening withinbody tissue for at least partial positioning within the body and anaccess housing mountable to the liner base. The access housing includesa housing member for positioning outside the body and defines apassageway dimensioned for permitting passage of either a surgeon's handor arm of a surgeon, a first seal member mounted to the housing memberand a second seal member mounted within the housing member adjacent thefirst seal member. The first seal member includes an inner seal portionand an outer seal portion. The inner seal portion has an aperture forsubstantial sealed reception of either the surgeon's hand or arm. Thesecond seal member also has an inner portion defining an aperture forsubstantial sealed reception of either the surgeon's hand or arm. Thefirst and second seal members form a substantial seal within thepassageway of the housing member in the absence of the hand or arm ofthe surgeon. However, during insertion of either the surgeon's hand orarm within the aperture of the first seal member, the inner seal portionof the first seal member is adapted to move to position the aperturethereof in at least partial overlapping relation with the aperture ofthe second seal member to permit passage of the surgeon's hand or armthrough the housing member. The outer seal portion of the first sealmember includes at least one expansible rib (preferably, a plurality ofribs) dimensioned to facilitate movement of the aperture of the firstseal member to a displaced position radially displaced from the firstseal axis.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the present disclosure will be betterappreciated by reference to the drawings wherein:

Preferred embodiments of the present disclosure will be betterappreciated by reference to the drawings wherein:

FIG. 1 is a perspective of the hand access apparatus in accordance withthe principles of the present disclosure illustrating the access housingand liner base;

FIG. 2 is a cross sectional view of the access apparatus in accordancewith the embodiment of FIG. 1 taken along lines 2-2 of FIG. 1;

FIG. 3 is a top plan view of a first seal within the access housing;

FIG. 4 is a side plan view of the first seal;

FIG. 5 is a top plan view of a second seal within the access housing;

FIG. 5A is a top plan view of an alternate embodiment of the secondseal;

FIG. 6 is a top plan view of the first and second seals with the secondseal depicted in phantom;

FIGS. 7-8 are views illustrating insertion of the hand access apparatuswithin an incision; and

FIG. 9 is a cross-sectional view similar to the view of FIG. 2illustrating radial movement of the first seal during insertion of anobject within the access housing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The surgical access apparatus of the present disclosure provides asubstantial seal between the body cavity of a patient and the outsideatmosphere before, during and after insertion of an object through theapparatus. Moreover, the access apparatus of the present disclosure isadapted for positioning within an incision and may retract the tissuedefining the incision to permit access to the underlying tissue. Theaccess apparatus is particularly adapted for accommodating the handand/or arm of a surgeon during a hand assisted laparoscopic procedureand establishing a gas tight seal with the arm when inserted. However,the access apparatus may be adapted to receive other objects, such assurgical instruments. The access apparatus is further adapted tosubstantially close in the absence of the object to maintain theintegrity of the insufflated peritoneal cavity.

Although the specific focus of this disclosure will be on a preferredlaparoscopic procedure, it will be noted that laparoscopic surgery ismerely representative of a type of operation wherein a procedure can beperformed in a body cavity with access through a body wall.

In the following description, as is traditional the term “proximal”refers to the portion of the instrument closest to the operator, whilethe term “distal” refers to the portion of the instrument remote fromthe operator.

Referring now to FIGS. 1-2, hand access apparatus 10 includes two maincomponents, namely, access housing 12 and liner base 14 which is mountedto the access housing 12. Access housing 12 is positioned external tothe body, preferably, in contact with the outer skin of the body andconsists of outer frame or housing member 16, seal support 18 disposedwithin the housing member 16 and first and second seals 20, 22. Housingmember 16 preferably defines outer flange 24 dimensioned for engagementby the surgeon and lower U-shaped flange 26. U-shaped flange 26 contactsthe skin of the patient upon application of access apparatus 10.U-shaped flange 26 also serves to mount liner base 14. Housing member 16defines housing axis “a” and internal longitudinal passageway 28extending through the housing member 16. Housing member 16 may be asingle piece component or alternatively incorporate multiple piecesassembled together by conventional means. In one preferred embodiment,housing member 16 incorporates two components 16 a, 16 b as depicted inFIG. 2. Housing component 16 b serves as a cover for enclosing first andsecond seals 20, 22 and is connected to housing component 16 a in fixedrelation.

Seal support 18 of access housing 12 is an elongated annular collarwhich extends at least partially within housing member 16. The uppersurface 30 of seal support 18 includes a plurality (two are shown) ofupstanding posts 32 peripherally spaced about the periphery of the uppersurface 30.

Referring now to FIGS. 3-4, in conjunction with FIGS. 1-2, first seal 16includes outer seal portion 34 and inner seal portion 36. Outer sealportion 34 defines a plurality of apertures 38 which receivecorresponding posts 32 of seal support 18 to mount first seal 20 to theseal support 18. Outer seal portion 34 also includes a plurality of ribs40 radially displaced about the outer seal portion 34. Ribs 40 define anundulating arrangement as shown in FIG. 4. The undulating arrangementpermits expansion of outer seal portion 34 particularly during offsetmanipulation of the object relative to housing axis “a”. Ribs 40 areeach preferably arranged along a line of intersection “b” with housingaxis “a” to permit uniform expansion and movement of first seal 20. Ribs40 may take other shapes and forms such as, for example, a sinusoidalconfiguration, pyramidal, convex, concave etc. . .

Inner seal portion 36 defines internal aperture or opening 42. Aperture42 is arranged about first seal axis “c” (FIG. 2) which is preferablyradially offset from housing axis “a”. Aperture 42 may be any suitablegeometrical shape including circular, elliptical, square, rectangular,or any other polygonal arrangement. In the preferred embodiment,aperture 42 is generally D-shaped. Inner seal portion 36 is adapted toradially move upon insertion of an object though aperture 42 asfacilitated by ribs 40 to permit the aperture 42 to assume a position ingeneral alignment with housing axis “a”.

With reference to FIG. 5, in conjunction with FIGS. 1-2, second seal 22includes outer seal portion 44 and inner seal portion 46. Outer sealportion 44 also includes apertures 48 disposed about its periphery forreception of posts 32 of seal support 18 to mount the second seal 22within housing member 16. Inner seal portion 46 defines opening oraperture 50 which may be of any geometrical shape, but, preferably, isgenerally D-shaped. Aperture 50 is arranged to be a mirror image ofaperture 42 of first seal 20. Aperture 50 is arranged about second sealaxis “d” which is radially offset from housing axis “a”. Alternatively,as depicted in FIG. 5A, aperture 50 may be centrally located withinsecond seal 22 with second seal axis “d” coincident with axis “a” ofhousing member 16. This arrangement may minimize the degree of movementrequired by first seal 20 and also positions the object in the center ofhousing member 16 during use. Second seal 22 may optionally includeexpansible ribs of the type aforedescribed in connection with first seal20.

First and second seals 20, 22 are each adapted to form a substantialseal about an object inserted through their apertures 42, 50 and maystretch to accommodate larger size objects. First and second seals 20,22 are preferably in juxtaposed contacting relation. First and secondseals 20, 22 may be formed of an elastomeric material includingcommercially available MONOPRENE™. In one preferred embodiment, seals20, 22 are fabricated from a resilient material, e.g., polyisoprene,with each having at least one layer of fabric material positionedadjacent the resilient material. Seals 20, 22 may be fabricated from anelastomeric material molded with a fabric material. A friction resistingcoating may be applied to seals 20, 22. Such seal is disclosed incommonly-assigned U.S. patent application Ser. No. 10/165,373 filed Jun.6, 2002, the contents of which are incorporated in its entirety byreference.

FIG. 6 illustrates in plan view the arrangement of first and secondseals 20, 22 (with second seal 22 shown in phantom) prior to insertionof an object within the apertures 42, 50 of the seals 20, 22. As shown,apertures 42, 50 of first and second seals 20, 22 are in non-overlappingrelation, and arranged so that the respective apertures of the first andsecond seal do not overlap. With this arrangement and with first andsecond seals 20, 22 in contacting relation, the seals 20, 22substantially seal longitudinal passageway 28 of housing member 16 toprevent escape of insufflation gases through access housing 12.

Referring again to FIGS. 1-2, liner base 14 of access apparatus 10 willbe discussed. Liner base 14 is intended for positioning within theincision of the patient to line the incision and/or retract the tissuedefining the incision thereby providing access to the underlying bodycavity. Liner base 14 includes liner member 52, and lower ring 54 andupper ring 56 mounted to respective ends of liner member 52. Linermember 52 may be a sheet of flexible material including, for example,polyethylene, polypropylene, etc., arranged in a tubular or sleeve-likeconfiguration.

Liner member 52 may also include an elastomeric material and mayincorporate rigid runners embedded within the material to increase itsrigidity. Although in the preferred embodiment, liner member 52 istubular, it is envisioned that the liner member 52 may incorporateseveral pieces, e.g., individual tabs or the like. Liner member 52 mayor may not be impervious to fluids. Liner member 52 is adapted to linethe incision so as to prevent contamination of the incision by anytissue which may be removed through the access apparatus, or in thecourse of the surgery. Generally, liner member 52 may also serve toretract the incision during placement of the liner base 14, so that thepatient's skin, fascia, and other tissue are drawn back, allowing accessto the surgical site.

Lower ring 54 of liner member 52 is adapted for positioning through theincision and beneath the abdominal wall to engage the interior wallportions to thereby secure liner base 14 relative to the incision. Lowerring 54 is preferably flexible to facilitate passage through theincision and possesses sufficient resiliency to return to its originalconfiguration upon entering the abdominal cavity. Lower ring 54 ispreferably annular or ring-like in configuration and may be fabricatedfrom a resilient or elastomeric material. Lower ring 54 may be fixedlysecured to the end of liner member 52 through conventional means.

Upper ring 56 is substantially identical to lower ring 54, i.e., upperring 56 is also annular or ring-like in configuration and is attached tothe other end of liner member 52 by conventional means. Upper ring 56 isreceived within U-shaped flange 26 of access housing 12 and is securedbetween the flange 26 and lower surface 58 of seal support 18 to secureliner base 14 to access housing 12. Other means for attaching upper ring56 to access housing 12 are also envisioned.

In further embodiments, seal support 18 discussed above in connectionwith FIGS. 1-9 is mounted to a different base for retracting theincision and preferably lining the incision. For example, the base 14may comprise a flexible sleeve for lining the incision and an inflatablemember at a proximal end of the sleeve for tensioning the sleeve. Otherstructures for the base 14 may be used as appreciated by those ofordinary skill in the art. The access apparatus 10 discussed above mayalso include an additional seal for sealing around the object insertedthrough the apparatus, such as a septum seal.

Operation

The use of the access apparatus 10 in connection with a hand assistedlaparoscopic surgical procedure will be discussed. The peritoneal cavityis insufflated and an incision is made within the cavity, with e.g., atrocar, to provide access to the cavity as is conventional in the art.Thereafter, as depicted in FIGS. 7-8, liner base 14 is introduced withinthe incision. Specifically, lower ring 54 is passed through the incision“i” and placed within the body cavity. As noted, lower ring 54 may becontracted upon itself to facilitate passage through the incision “i”and then released to permit the lower ring 54 to return to its normalcondition (under the influences of its inherent resiliency) within thecavity. Liner member 52 extends from lower ring 54 through the incisionto line the incision as previously discussed.

With reference to FIG. 9, the procedure is continued by positioningaccess housing 12 adjacent the external body tissue with the outersurface of U-shaped flange 26 engaging the tissue surrounding theincision. Thereafter, an object such as the surgeon's hand or arm “o” isintroduced within access housing 12 and advanced through aperture 42 offirst seal 20. As noted, inner seal portion 36 of first seal 20 movesradially as facilitated by expansion of ribs 40 to permit aperture 42 toat least partially overlap with aperture 50 of second seal 22 therebypermitting the surgeon to continue advancing his arm through accesshousing 12 and liner base 14. The surgeon continues to advance his armthough aperture 50 of second seal 22 and within the abdominal cavity.

With access apparatus 10 in this position of FIG. 9, hand assistedsurgery may then be effected by continued advancement of the surgeon'shand and arm through seals 20, 22 of access housing 12 and into the bodycavity. Seals 20, 22 form a fluid tight seal about the arm. The desiredhand assisted procedure may then be performed.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1. A surgical access apparatus, which comprises: a housing memberdefining a housing axis and a passageway therethrough, the housingdimensioned for passage through tissue; a first seal member mountedacross the passageway, the first seal member having proximal and distalend faces and a defining a seal passage for permitting passage of asurgical object in substantial sealed reception therewith, the firstseal member including at least one expansible segment, the expansiblesegment including a protruding rib extending in a proximal directionfrom the proximal end face and a corresponding recess defined within thedistal end face and aligned with the protruding rib, the expansiblesegment arranged to extend radially generally toward and away from thehousing axis, and being dimensioned and adapted to facilitate radialmovement of the seal passage during manipulation of the object withinthe first seal member; and a second seal member mounted across thepassageway distal of the first seal member, the second seal memberdefining a seal passage for substantial sealed reception of the objectand being arranged about a second seal axis radially displaced from thefirst seal axis, the second seal member including at least oneexpansible segment dimensioned to facilitate radial movement of the sealpassage of the second seal member during manipulation of the object, theexpansible segment of the second seal member including a protruding ribextending in a proximal direction from the proximal end face and acorresponding recess defined within the distal end face and aligned withthe protruding rib.
 2. The surgical access apparatus according to claim1 wherein the expansible segment is generally linear.
 3. The surgicalaccess apparatus according to claim 2 wherein the expansible segment isgenerally arranged along a line of intersection with the housing axis.4. The surgical access apparatus according to claim 1 wherein the firstseal member includes a plurality of expansible segments.
 5. The surgicalaccess apparatus according to claim 3 wherein the expansible segmentsare each generally linear.
 6. The surgical access apparatus according toclaim 5 wherein the expansible segments are each generally arrangedalong a line of intersection with the housing axis.
 7. The surgicalaccess apparatus according to claim 1 wherein the at least oneexpansible segment of the second seal member is generally arranged alonga line of intersection with the housing axis.
 8. The surgical accessapparatus according to claim 1 wherein the first seal member and thesecond seal member are arranged so that their respective seal passagesdo not overlap in the absence of the object positioned therein.
 9. Thesurgical access apparatus according to claim 8 wherein each of the sealpassages of the first seal member and the second seal member aregenerally open passages in the initial condition thereof.
 10. Thesurgical access apparatus according to claim 8 wherein the seal passageof the second seal member is in general alignment with the centralhousing axis.
 11. The surgical access apparatus according to claim 8wherein the first seal member and the second seal member are dimensionedand adapted to form a substantial seal within the passageway of thehousing member in the absence of the object inserted within the apertureof the first seal member.
 12. The surgical access apparatus according toclaim 1 including a liner base mountable to the housing member, theliner base adapted for insertion through an incision to line theincision and/or retract the tissue defining the incision therebyproviding access to the underlying body cavity.
 13. The surgical accessapparatus according to claim 1 wherein the seal passage of the firstseal member is adapted for substantial sealed reception of either asurgeon's hand or arm.
 14. The surgical access apparatus according toclaim 1 wherein the expansible segments define one of an undulating,sinusoidal, pyramidal, convex, or concave configuration.